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FDA 510(k)

Volumetric Specimen Imager

K-Number: K192939 · 2019-12-27

ApplicantClarix Imaging
Decision Date2019-12-27
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Volumetric Specimen Imager is a medical device manufactured by Clarix Imaging. It received FDA 510(k) clearance on 2019-12-27 under approval number K192939. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Volumetric Specimen Imager?

Volumetric Specimen Imager is a medical device that received FDA 510(k) clearance on 2019-12-27. It is manufactured by Clarix Imaging. The 510(k) number is K192939.

When was Volumetric Specimen Imager approved by the FDA?

Volumetric Specimen Imager received FDA 510(k) clearance on 2019-12-27, under approval number K192939.

What company makes Volumetric Specimen Imager?

Volumetric Specimen Imager is manufactured by Clarix Imaging.

What is the FDA product code for Volumetric Specimen Imager?

The FDA product code for Volumetric Specimen Imager is MWP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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